BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMALL BONE FAS TAK, TAPERED NEEDLE WITH #2-0 FIBERWIRE

    MDR report key: 1051787 · Received May 22, 2008

    Report

    Report Number
    1220246-2008-00094
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ARTHREX INC.
    Product Code
    NOV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR EVAL AND THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBERWIRES IN THE ANCHORS BROKE DURING IMPLANTATION. THE SUTURES WERE DISCARDED BUT THE METAL ANCHORS WERE LEFT INTACT IN THE PT. THE SURGERY WAS DELAYED OVER 30 MINUTES BUT NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. NO FURTHER PT INFO IS AVAILABLE FROM THE CUSTOMER. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL BONE FAS TAK, TAPERED NEEDLE WITH #2-0 FIBERWIRE SUTURE ANCHOR DEVICE NOV ARTHREX INC. NA 140278

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK